BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3800826 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02122
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS EVER SINCE RECEIVING A REPLACEMENT INSULIN PUMP. IT WAS STATED THAT THE PATIENT PROGRAMMED A TEST BOLUS OF 2.7 UNITS, AND IN THE PATIENT'S OPINION, THE DROP OF INSULIN WAS TOO SMALL. THE PATIENT FELT THAT THE UNIT WAS NOT DELIVERING ACCURATELY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. NO DAMAGE TO THE DRIVE SUPPORT CAP WAS NOTED. THE UNIT PASSED THE PRIME AND HIGH PRESSURE TESTS. ALSO FOUND NO DELIVERY ALARMS IN THE ALARM HISTORY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279432 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1